§803.56. If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports? — Inbound Citations

Abbreviated new drug application (ANDA) has the same meaning given the term “abbreviated application” in § 314.3(b) of this chapter.

(3) You are also responsible for conducting an investigation of each event and evaluating the cause of the event. If you cannot submit complete information on a report, you must provide a statement explaining why this information was incomplete and the steps you took to obtain the information. If you later obtain any required information that was not available at the time you filed your initial report, you must submit this information in a supplemental report under § 803.56 in accordance with the requirements of § 803.12(a).

(1) Report to FDA in accordance with §§ 803.50, 803.52, 803.53, and 803.56;